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TCT 2010: SYNTAX Trial
1. Press Conference Transcatheter Aortic Valve Implantation in Inoperable Patients with Severe Aortic Stenosis Martin B. Leon, MD on behalf of the PARTNER Investigators TCT 2010; Washington, DC; September 23, 2010
2. PARTNER Study Design Total = 1058 patients n=358 n= 700 2 Parallel Trials: Individually Powered High Risk Inoperable ASSESSMENT: Transfemoral Access ASSESSMENT: Transfemoral Access High Risk TA High Risk TF 1:1 Randomization 1:1 Randomization 1:1 Randomization Not In Study TAVI Trans femoral Surgical AVR Standard Therapy (usually BAV) TAVI Trans femoral Surgical AVR TAVI Trans femoral VS VS VS Primary Endpoint: All Cause Mortality (1 yr)(Non-inferiority) Primary Endpoint: All Cause Mortality over length of trial (Superiority) Symptomatic Severe Aortic Stenosis ASSESSMENT: High Risk AVR Candidate 3105 Total Patients Screened
3. Primary and Co-Primary Endpoints PRIMARY: All-cause mortality over the duration of the study Superiority test (two-sided), 85% power to detect a difference, α = 0.05, sample size = 350 total patients CO-PRIMARY: Hierarchical composite of all-cause mortality and repeat hospitalization Non-parametric method described by Finkelstein and Schoenfeld (multiple pair-wise comparisons) > 95% power to detect a difference, α = 0.05 Positive study if both endpoints P < 0.05, or if either endpoint is < 0.025
4. Study Devices Retroflex 1 Edwards-SAPIEN THV 23mm and 26mm valve sizes 22F and 24F sheath sizes
5. Inclusion Criteria Severe calcific aortic stenosis defined as echo derived valve area of < 0.8 cm2(EOA index <0.5cm2), and mean gradient > 40 mmHg or jet velocity > 4.0 m/s NYHA functional class II or greater Risk of death or serious irreversible morbidity as assessed by cardiologist and two surgeons must exceed 50%
6. All Cause Mortality Standard Rx TAVI HR [95% CI] =0.54 [0.38, 0.78] P (log rank) < 0.0001 All-cause mortality (%) Months
7. All Cause Mortality Standard Rx ∆ at 1 yr = 20.0%NNT = 5.0 pts TAVI 50.7% All-cause mortality (%) 30.7% Months
8. Finklestein & Schoenfeld Analysis(hierarchical multiple pair-wise comparison) Compare, at random, every TAVI patient with every Standard Rx patient; 179 x 179 (32,041) patient pairs, which did better? #1, compare “time to death” 72% chance that we know who died first If so, 63% chance that Standard Rx patient died first and 37% chance that TAVI patient died first #2, if necessary, compare “time to repeat hospitalization” 17% chance that we know who had repeat hosp first If so, 75% chance that Standard Rx patient had repeat hosp first and 25% chance that TAVI patient had repeat hosp first FS Method Produces a P-value < 0.0001
11. Six-Minute Walk Tests Walking Distance P = 0.002 P = 0.67 P = 0.004 P = 0.55 Walking distance (meters) Baseline 1 Year 30 Days
12. Percent TAVI Standard Rx TAVI Standard Rx TAVI Standard Rx TAVI Standard Rx Treatment Visit Baseline 30 Day 6 Month 1 Year NYHA Class Over TimeSurvivors P = 0.68 P < 0.0001 P < 0.0001 P < 0.0001 I II III IV
13. Standard Rx 70 TAVI 44.6 44.4 60 39.5 50 33.0 40 Mean Gradient (mm Hg) 30 43.2 12.1 11.3 10.8 20 10 0 Mean Gradients Over Time P < 0.0001 6 Months N=100 1 Year N=89 Baseline N=163 30 Day N=143 Error bars = ± 1 Std Dev
14. 30 Day 6 Month 1 Year Paravalvular Regurgitation: TAVI No changes over time None/Trace Moderate Mild Severe
